Presented by the Joint United Nations Programme on HIV/AIDS (UNAIDS), The Global Fund to Fight AIDS, Tuberculosis and Malaria, and the Microbiology & Infectious Diseases Discussion Group at the New York Academy of Sciences, HIV 2015: Using Phylogenetics to Enhance the HIV Response will take place on Thursday, June 4, 2015 at 9:00 AM – 5:00 PM at The New York Academy of Sciences.
Learn moer about the event here: http://www.nyas.org/Events/Detail.aspx?cid=1db34692-7883-4ea0-9231-39386…
New data from a trial looking at the individual health benefits of starting those living with HIV on antiretroviral therapy (ART) at CD4 cell counts above 350 were released today. The data, from a trial known as START, are further evidence in support of the expansion of ART access worldwide. The data from START should also start the clock on even more substantial engagement with the types of ART programs that are most likely to help people make informed choices to begin and remain on life-saving treatment.
It’s now been nearly four years since the release of trial data showing that people living with HIV who started ART at CD4 cell counts between 350 and 500 were significantly less likely to transmit HIV to their sexual partners, compared with people who started according to national guidelines. That trial—known as HPTN 052—may be the single most important factor behind today’s push to use ART to end the epidemic.
In case you’ve been pre-occupied with other parts of the AIDS response like, for example, the war on drug users in Russia or the imperiled VMMC programs in Africa, see UNAIDS’ 90-90-90 campaign for the frontline example of the ART-to-end-AIDS message. AVAC and other allies have been working with UNAIDS, PEPFAR and governments to try to ensure that this message is accurately conveyed and understood as encompassing prevention beyond ART—including saturation-level coverage of VMMC, targeted PrEP, harm reduction and male and female condoms. For more on this work—and why prevention is “on the line” see our most recent Report.
In the wake of early data from HPTN 052, people living with HIV and their allies were quick to point out that the strongest evidence this trial provided was about the prevention benefit of starting ART “early” (i.e., before national guidelines). HPTN 052 did find that earlier initiation had clinical benefits for the individual, including delaying the time to AIDS events, death and tuberculosis. But for many advocates and activists, these data were not definitive and that a real answer would have to come from the START trial, which was a randomized investigation of exactly this question: does immediate initiation of ART improve individual health for people living with HIV?
Today the answer came in, early, and with resounding clarity: Yes.
The START trial, which enrolled 4,685 people at 215 sites in 35 countries (twenty-seven percent of the participants are women, and approximately half are gay men) looked at rates of AIDS, and serious AIDS-defining illness or death in people with CD4 cell counts above 500 who started ART on enrollment in START, versus those participants who also had CD4 cell counts above 500 and delayed treatment until the initiation criteria dictated by the clinical guidelines in their countries.
At a scheduled interim review of the data, the trial’s Data and Safety Monitoring Board (DSMB) found compelling evidence that the benefits of starting antiretroviral treatment immediately at CD4 cell counts above 500 cells/mm3 outweigh the risks. This conclusion was based on the fact that, over an average follow-up period of three years, the risk of AIDS, other serious illnesses or death was reduced by 53 percent among those in the “early” treatment group versus those who started treatment according to national guidelines.
START effectively validates the direction that the WHO’s Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection had begun to take—initiation regardless of CD4 cell count in many populations, including pregnant women, children under the age of five, and people in serodiscordant couples. And it may settle some concerns about whether earlier initiation was good for the person living with HIV—or just for his or her sexual partners and/or potential children.
But it’s critical to recognize that figuring out when to start is only part of the puzzle. The question of how to start is equally critical and isn’t going to be settled by any randomized trial. The how concerns the environment in which individuals are offered treatment, the services that are part of that offer—peer support, community-based refills, non-biased provider care, among others—and the ways that the decision to start is framed. Even with clinical and public health benefits, ART may not be for everyone as soon as they are diagnosed. Issues with disclosure exist everywhere and are compounded in places where laws criminalizing HIV are on the books.
At a time when funding for civil society organizations is dropping everywhere—and when some PEPFAR country programs are placing funding for community engagement as “near- or non-core” (pieces of USG jargon that set priority for PEPFAR funding) —and when UNAIDS has yet to step forward with staunch, straightforward condemnation of rights-violating legislation and hate speech by politicians, this “How?” question is far from resolved.
That’s why START has to be welcomed for what it is—a clear answer to a critical question. And also understood for what it is not—an answer to the urgent challenge of how best to truly seek to end the epidemic with comprehensive prevention programs that include, but are not restricted to, delivering ART so that everyone who wants it can start it, stay on it, achieve virologic suppression and, more importantly, a life lived with health, dignity and joy.
FHI 360 in collaboration with WHO, UNAIDS and AVAC have announced the upgrade of the Clearinghouse on Male Circumcision for HIV Prevention website — a collaborative effort between these organisations. The new design comes with enhanced form and functionality that will ensure more user-friendly navigation, a modern look, an enhanced search function, an interactive map and a new resources library among other things. Please visit www.malecircumcision.org!
Since its creation in 2009, the Clearinghouse has been an important platform for the generation and sharing of information and resources with the international public health community, civil society groups, health policy makers and program managers involved in efforts to scale-up voluntary medical male circumcision (VMMC) for HIV prevention.
VMMC is one of the most powerful and cost-effective HIV prevention tools at hand. Studies from 2005 showed that it reduces a man’s risk of acquiring HIV from a female partner by up to 60 percent, increasing to around 75 percent over time. VMMC is now being rolled out for HIV prevention in 14 sub-Saharan African countries with high HIV prevalence and low levels of adult male circumcision with the goal of achieve 80 percent coverage among men in these countries in order to avert 3.4 million new HIV infections and save US$16.6 billion in future healthcare costs.
I’m writing this piece because I think that what I have to say will help people think differently or more effectively or strategically about the xenophobic attacks happening in South Africa and the acts of violence, abuse and terrorism taking place in different parts of this beautiful continent, Africa, that I call home. At the very least, I hope that I’ll convince you that you should.
So, “What does xenophobia, terrorism or violence have to do with biomedical HIV prevention?” one may ask. Everything! Over the last several years, I’ve had the privilege of working with hundreds of young women and girls. Sub-Saharan Africa has the biggest burden of HIV/AIDS, and women are disproportionally affected. As such, they are in desperate need of HIV prevention options tailored to meet their unique needs. In addition to this, women and girls need options for empowerment; they need to be in school; they need protection and security; and they need employment among other things. Xenophobia, racism, terrorism and violence make it so much harder to reach these women [and men], for them to access existing strategies, and to conduct important research that would bring these options to the shelves.
Growing up I was always socially aware of my surroundings both my maternal and paternal families were involved in the struggle for freedom in South Africa. I believe that my being an activist is because of this very reason. I grew up knowing that when something was wrong, I had to stand up and do something about it. However my reasons for writing this are more personal than political. My maternal granny being the matriarch in my family lived UBUNTU [a Nguni Bantu term that refers to human kindness or to the belief in a universal bond of sharing that connects all humanity]. She would cook a big pot of pap everyday – more than our big family would need [pap is a staple food of the Bantu inhabitants of Southern Africa, made of porridge made from ground maize].
“If someone walked in and were hungry, we would at least be able to offer them pap,” she always said. My granny had rich tales about life. She told us about discrimination and its effects. It was the coolest thing to sit at her feet and hear her tell tales of how her family is everywhere in the diaspora. One tale stands out todate. She told us about her niece who went to Malawi and never came back. I vividly remember the pain in her eyes when she told us this story. “I long to see Emily one more time before I join my ancestors,” is exactly as she put it.
As luck would have it, one day we received a visit from another aunt, Martina, who came to tell my granny she heard some details of where aunt Emily was. She was still in Malawi and aunt Martina volunteered to go and fetch her. My granny gave aunt Martina all her savings so she could go fetch her niece and finally bring her home. When aunt Martina arrived there, aunt Emily was so sick she could not travel back with her. Aunt Martina also not allowed take aunt Emily with her since she was married and even though her husband had passed away she “belonged” to her Malawian in-laws. That is what the elders told my aunt Martina. Aunt Martina stayed a while looking after aunt Emily and her two young kids Isa and Hassim. However a few weeks after my aunt’s return to South Africa aunt Emily died in Malawi and left her young kids orphaned. Words cannot express how much this hurt my granny. The pain was indescribable! Everyday at 5am, granny would pray that Isa and Hassim were safe. Years passed and one day someone who knew our family well walked through our gate with a young boy – very tall , with sharp features. My granny jumped up and hugged this 16 year old without anyone saying a word about who this boy was. The man who brought the boy explained to us that it was Hassim and that he came into his work place asking about my granny and our family based on the stories his mom told them as kids. My granny was the happiest I’ve seen her all my life.
Hassim stayed with us – a natural transition for us because growing up, we were always more than twelve grandchildren. His presence therefore made no difference or was not an extra burden. But the joy of Hassim’s company was shortlived. One day he woke up and told granny that he was going back to Malawi to fetch his sister Isa. Once again my granny emptied her purse and gave Hassim every single cent she had. Although we hoped that it would be easier for Hassim to return now that he knew the way back home, a few years passed but Hassim never returned. During this time, my granny passed away.
And then one day, my mom received a call, “Granny we are in Johannesburg,” said the voice on the other end of the line. It was Hassim. “The gentleman we travelled with from Beit Bridge did not want to drive through the route I knew in Louis Trichardt so we ended up in Johannesburg,” Hassim explained. My mom saved the number he called from thinking that she would call back as soon as we as a family had a plan on how to find out where in Johannesburg they were. When my mom called back she got that familiar dreaded response, “The subscriber you have called is not available at the moment”. Despite numerous attempts over several weeks, the result was always the same. Everyone at home with a phone saved that number and took turns trying it hoping that one of us would finally get through with no avail. And that is how we lost Hassim and Isa in this big bad Johannesburg.
That is partly why the fight for a better Africa is so personal to me. I do not mention in my writing the words hate, religion, culture, politics, exile, or the new trendy hashtags. Here is why. My aunt left home for Malawi because she hated the political situation in her country of birth She never returned. She was refused the opportunity to return home because of religion and culture. What is happening in Africa currently should appeal to our personal. I do not know what your personal is but I am aware that I could have easily lost a family member in the Kenyan Wastegate Mall killings or one of the girls in the Chibok kidnappings could easily have been my niece or a student at Garrisa could have been related to me; and the young men and women with features so clearly the same as mine being chased around and burnt in the streets of South Africa could easily be my own Hassim or Isa.
Africa who taught you to hate You? I just don’t get it!
We must bring these issues home – for they are home! Everyone of us in their small but incremental way. This is why I and a group of friends have opened up, not a Facebook page or started a hashtag, but our homes and our hearts just like how my ganny taught me. My home is open to anyone who knows someone who is in trouble and needs help during the spate of disgusting attacks on Africans by Africans. I know that my granny’s legacy is not that of fear of the challenges and troubles before me, but that of love and compassion. And that legacy lives in me, in my friends and in many others who are taking small but steady and bold steps towards making their communities, their country and Mother Africa a better place for us and for future generations!
Today is HIV Vaccine Awareness Day. For our full 2015 Toolkit, click here. This blog, by Mitchell Warren AVAC’s Executive Director, first appeared on The Hill.
In 1995, nine HIV treatment activists joined together to speed the search for an AIDS vaccine. With the global epidemic raging and truly effective HIV treatments still unavailable, they focused their advocacy on the research institutions best positioned to drive new breakthroughs, especially the US National Institutes of Health (NIH).
Two decades later, the movement they started has achieved remarkable success. The search for an effective vaccine is in its most promising phase ever, with some 30 different candidates in the pipeline reflecting an exciting array of scientific approaches. A series of related advances – from early antiretroviral therapy (ART) to a daily prevention pill – are already transforming the global AIDS response and saving lives. For the first time, we can honestly talk about how to end the AIDS epidemic – and we have not only researchers, advocates, and trial participants to thank, but also American taxpayers.
But we don’t yet have all the tools we need. That’s why it is dismaying that some members of Congress have chosen this moment to call for scaling back the nation’s investments in HIV research. Instead, we should be looking for ways to make these investments even more impactful, to continue leading the world into a future without AIDS.
The threat to research investments is partly the product of their success. In 2005 and 2006, NIH-funded trials found that male circumcision can reduce a man’s risk of HIV infection by nearly two-thirds. In 2011, a landmark NIH study found that ART slashes the risk of HIV transmission by 96 percent. Beginning in 2010, a series of trials backed by NIH and the US Centers for Disease Control and Prevention showed that daily use of an HIV treatment medicine by people who are HIV-negative can reduce their risk of becoming infected by 90 percent or more.
It’s these advances that led to widespread talk of the “end of AIDS.” In hindsight, that talk might have backfired, creating the misperception that we can begin to ease up on the accelerator.
In fact, about 2.1 million people still become infected with HIV every year, including 50,000 in the United States. With current prevention options we can get that number way down – but nowhere near zero. The NIH’s own Anthony Fauci has spoken compellingly about how, in any realistic scenario, an effective vaccine and other new prevention tools are still essential to halt new HIV infections.
A vaccine isn’t just needed, it’s also very possible. Just this year, researchers launched studies that could lead to the first vaccine licensed for use. While it won’t be the perfect vaccine, it could make a real difference if proven to be even partially effective.
Meanwhile, basic science is opening up whole new areas of vaccine discovery, such as use of “broadly neutralizing antibodies.” These are immune system proteins that emerge in some people who are already infected HIV. Now, researchers are figuring out how to engineer them in the lab and offer them to HIV-negative people as a way to protect against infection. A whole range of other strategies are also in development, in the lab or in early human trials.
Dr. Fauci has done an admirable job of arguing for sustained research into AIDS vaccines and other approaches. But we can’t rely on any single voice to make our case. The entire AIDS community needs be speaking out in support of smart, strategic and well-funded HIV prevention research programs.
Within Congress itself, remaining backers of HIV research must stand up for the programs they’ve supported in the past. They need to make the case to colleagues, and the nation, for sustaining this work until the job is done. And they need to hold the research community accountable for making the most strategic use of taxpayer resources.
My organization is the product of the nine advocates who came together 20 years ago. Like HIV prevention itself, we’ve changed in unexpected ways. But the basic idea remains the same – that an effective AIDS vaccine is essential to ending one of modern humanity’s greatest tragedies. This is an idea we’ll be repeating on HIV Vaccine Awareness Day, May 18, and throughout the year.
The future path of science is never clear. But we can be certain that slowing down now would be a huge mistake – for American scientific leadership, and for millions of people whose lives depend on it.
Warren is Executive Director of AVAC, an advocacy organization for the elimination of HIV/AIDS.
The AIDS vaccine field has been energized by the recent launch of early clinical trials in South Africa – trials that could eventually lead to the first vaccine licensed for use. The vaccine being tested is a modified and hopefully improved version of the first and only AIDS vaccine candidate thus far to show moderate efficacy in preventing HIV infection in the RV144 trial in Thailand that finished in 2009.
This vaccine candidate will only move to large-scale efficacy trials – which are the prerequisite for licensure – if researchers decide it has a good chance for success. How will they know, and when will they know it?
The answers were outlined for advocates by the HVTN’s Glenda Gray on the AVAC webinar to mark HIV Vaccine Awareness Day (HVAD) 2015.
Gray discussed an ongoing trial of the ALVAC-protein vaccine candidate, HVTN100, which started in January 2015 in South Africa. By June 2016, there should be 12 months of data available about what kind of response the vaccine triggered among the 210 participants who received the experimental vaccine.
The specific requirements are quite technical, but basically the researchers will look at 12-month immune responses in HVTN100 and gauge the likelihood that the vaccine would maintain at least 50% efficacy for two years in the future efficacy trial. The Thai trial showed 31% efficacy overall. So if all goes according to plan in terms of timing and reaching a “go” decision, a vaccine efficacy trial with this ALVAC-protein prime-boost could start in early 2017.
On the webinar Gray also provided an update on the other planned HVTN clinical trials as part of the P5 partnership, as well as a new collaboration with the HIV Prevention Trials Network (HPTN) to advance one of the broadly neutralizing antibodies (bNAbs) into a possible efficacy trial as passive antibody prevention.
Also on the call Frank Tomaka of Janssen Pharmaceuticals, part Johnson & Johnson, presented their plans for clinical trials of his company’s new mosaic AIDS vaccine candidate using adenovirus type 26 as the vector. The suite of current trials that would lead to a possible efficacy trial in 2017 represent a significant investment by the company and welcome return of pharmaceutical industry financial investment in AIDS vaccine product development.
Finally, Bill Snow of the Global HIV Vaccine Enterprise reflected on the exciting progress in the field: after frustrating delays, we are now seeing clinical trials evaluating a trio of different approaches – ALVAC pox-protein, Ad26 mosaic, and bNAbs – that could move into efficacy trials in the coming 18-24 months. See AVAC’s new infographic for a visual display of this energized field.
An audio recording of the webinar and the presenters’ slides can be found here.
The purpose of this open-label 12-month study, sponsored by Emory University, is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men in South Africa.
Ugandan advocate, Sylvia Nakasi joined the rest of the world to commemorate HIV Vaccine Awareness Day on May 18 by writing a thoughtful opinion piece in the New Vision. In her piece, Sylvia highlights how far HIV vaccine research and devlopment has come and calls for the need for continued investments in the search for an effective HIV vaccine. Sylvia also underscores the need to ensure that the options that are currently available – including treatment, voluntary counseling and testing, voluntary medical male circumcision, male and female condoms, pre-exposure prophylaxis (PrEP) etc – reach the people who need them the most. Sylvia is a Policy and Advocacy Officer at Uganda Network of AIDS Service Organisations (UNASO) and was an AVAC Advocacy Fellow in 2011.
HIV Vaccine Awareness Day (HVAD), an annual commemoration of the need for and commitment to the ongoing search for a vaccine, is on May 18. AVAC is pleased to join partners across the globe in observing the progress in vaccine research.
Over the last year, data from a range of studies have advanced our understanding of vaccine science, from “classic” vaccine strategies to newer approaches with broadly neutralizing antibodies (bNAbs). These include the launch of a clinical trial in South Africa testing a vaccine building on the success of RV144 in Thailand, as well as data on passive immunization with bNAbs. These advances and more will be featured in an upcoming AVAC webinar—Vaccines in Vivo: AIDS vaccine clinical trials in 2015—on May 18.
UPDATE: Slides and audio now available — click here.
The webinar is a continuation of a year-long series of web-based dialogues on HIV prevention and implementation, the most recent of which focused on advances in neutralizing antibody research and passive immunization. Click here to access the recording.
In addition to the webinar update next week, we are also releasing our annual HVAD Toolkit, which is designed to help explain vaccine science in simple language. This year’s edition includes a set of simplified, updated infographics, fact sheets and other tools outlining key advances in the field.
Click here to visit our HVAD page and download the toolkit.
The Toolkit includes the following resources:
We welcome any comments, questions, suggestions and requests for these materials; please be in touch. AVAC also maintains tables, timelines and other information about ongoing and planned vaccine and other HIV prevention trials at www.avac.org/pxrd.
We look forward to commemorating another HVAD with all of you as we continue to pursue the goal of a vaccine to prevent HIV.
On Monday, May 18, advocates around the world will observe HIV Vaccine Awareness Day (HVAD)—an annual commemoration of the need for and commitment to the ongoing search for a vaccine. We invite you to join us on the day for a webinar—Vaccines in Vivo: Advances in AIDS Vaccine Research—at 10am US ET / 4pm South Africa / 5pm East Africa time (check www.timeanddate.com for your local time). We are also updating materials for vaccine advocates, including our “HVAD Toolkit” for those interested in easy-to-digest research updates.
This year brought the launch of long-awaited initiation of clinical trials building on positive results from the RV144 “Thai” trial. This effort is led by the Pox-Protein Public-Private Partnership (P5), including the the HIV Vaccine Trials Network, who will join the webinar to provide a status update of their current vaccine research and development program. We will also feature Janssen, part of Johnson & Johnson, to provide an overview of the research program they are moving forward that focuses on a cross-clade vaccine product.
Join this webinar if you’d like to understand:
Click to register for the webinar.
This webinar will be the next installment in our Prevention on the Line series, a year-long dialogue on pressing issues in HIV prevention research and implementation.
For advocates planning HVAD activities or simply looking for an update on the latest in the field, AVAC is updating its “HVAD Toolkit”, which includes a range of materials with HIV vaccine research highlights. The updated Toolkit will be available shortly at www.avac.org/hvad. Please email us if you’re looking for a specific resource right away.
We look forward to commemorating another HVAD with all of you as we continue to work toward the ultimate goal of a vaccine to prevent HIV. AVAC would especially like to thank the Bill & Melinda Gates Foundation, International AIDS Vaccine Initiative, the US Agency for International Development, and our civil society partners in countries for supporting and partnering in HVAD and other vaccine advocacy initiatives.
We look forward to hearing your voices and questions in this discussion. And, as always, please email us at avac@avac.org with questions, comments and suggestions.
